Field of the Invention
The present invention relates generally to an intelligent injection device. More specifically, the present invention relates to an insulin injector with intelligence and communication capabilities that is capable of providing optimized bolus doses of insulin based on information received from a glucose sensor. Embodiments also relate to injectors that communicate data within a health system to provide information to interested parties including the patient and their healthcare provider.
Description of the Related Art
Diabetes is a group of diseases marked by high levels of blood glucose resulting from defects in insulin production, insulin action, or both. Diabetes can lead to serious complications and premature death, but there are well-known products available for patients with diabetes to help control the disease and lower the risk of complications.
Treatment options for diabetics include specialized diets, oral medications and/or insulin therapy. The primary goal for diabetes treatment is to control a diabetic's blood glucose level in order to increase the chances of a complication-free life. Because of the nature of diabetes and its short-term and long-term complications, it is important that diabetics have a constant awareness of the level of glucose in their blood. For patients who take insulin therapy, it is important to administer insulin in a manner that maintains glucose level, and accommodates the tendency of glucose concentration in the blood to fluctuate as a result of meals and other activities.
Diabetics' bodies have difficulty regulating the production of insulin to manage glucose concentration in their blood. Accordingly, a primary goal of insulin therapy is to help the patient maintain a healthy glucose concentration. Two main components of insulin therapy are measuring glucose level, and delivering insulin as needed. Some diabetics use finger sticks to draw blood samples and test for glucose level, and multiple daily injections (MDI) of insulin. This type of therapy is relatively simple, but requires multiple daily finger sticks and needle injections, which are inconvenient and painful. In addition, the control of glucose is relatively crude, since glucose is measured only episodically, and insulin is delivered episodically with each injection.
Insulin pens typically provide the ability to set a dose. Accordingly, a patient can determine how much insulin they need and set the appropriate dose, and then use the pen device to deliver that dose. This system, however, requires a higher level of sophistication and involvement on the part of the patient.
At a more sophisticated level, other diabetics use insulin pumps to deliver a basal rate of insulin continuously. Insulin pumps may also provide bolus doses of insulin as needed. Insulin pumps are an improvement because they deliver insulin continuously, rather than episodically. They typically include a refillable or replaceable insulin reservoir. They also avoid most of the needle sticks associated with MDI. However, pumps have disadvantages because they can be inconvenient for the user to wear, and require tubing connected to an insertion set at the injection site. They are also expensive since they require electronics and an accurate pump mechanism.
Patch pumps are an insulin delivery device that generally falls between MDI and sophisticated insulin pumps. Patch pumps are typically disposable devices that stick to the patient's skin, and include an insulin reservoir, and a cannula insertion mechanism. Patch pumps may have, but do not require, electronics. They typically include a reservoir of insulin containing a three day supply of insulin for delivery to the patient. Patch pumps may provide a basal rate of insulin, either electronically or mechanically metered, and may also optionally provide bolus doses. There are some patch pumps that deliver only bolus doses. Patch pumps are typically disposable after their roughly three days of use, but some patch pumps may include both durable and disposable components.
There are typically two methods for measuring a user's blood glucose level. One method uses an electronic blood glucose meter wherein a sample of blood is obtained by piercing the skin of a user with a lancet. The sample of blood is then placed on a chemically-active test-strip, which interfaces with the blood glucose meter. Within several seconds of inserting the test-strip into the blood glucose meter, the blood glucose level of the user is read and shown on the digital display of the blood glucose meter.
The blood glucose meter method provides an accurate snapshot of a user's blood glucose level at a single moment in time. However, the blood glucose meter method does not indicate whether the user's glucose level is rising, falling, or steady. Additionally, the blood glucose meter method fails to capture a user's changing blood sugar levels after meals, between meals, and during the night.
Insulin delivery devices and glucose sensors may be combined to provide better therapy. An idealized “artificial pancreas” system would continuously measure glucose levels, and continuously communicate with an insulin delivery device to continuously deliver appropriate amounts of insulin through feedback and determinations. Such a system would also preferably capture glucose measurement and insulin delivery data and provide such information to the patient and their healthcare provider. However, the “artificial pancreas” concept requires expensive equipment, and requires the user to wear an insulin pump with an insertion set and related tubing, which many find inconvenient. While daily injections of insulin are effective for many, daily injections could be improved with adjustable dosing and dosing based on real time or near real time data. However, the currently exist no systems in which there is an interaction between monitored glucose levels, injections of insulin, and the recording of daily events.